Catalog Number

M1523-0

Brand Name

N/A

Version/Model Number

M1523-0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BYX

Product Code Name

TUBING, PRESSURE AND ACCESSORIES

Public Device Record Key

935a081e-1c5b-4346-b0e3-59a88e9c5c0d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 16, 2016

Package DI Number

10607411888882

Quantity per Package

25

Contains DI Package

00607411888885

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-